CompletedPhase 4

Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment

United States147 participantsStarted 2019-07-15

Plain-language summary

This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity)
. Age ≥ 21 years and ≤ 70 years
. Eligible female patients will be:
. Subjects must:

Exclusion criteria

. Pregnant or nursing, or plans to become pregnant in the next 9 months.
. Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg)
. Type 1 diabetes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1: Percent Weight Loss

Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)

Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss

Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)

Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100.

Timeframe: Baseline (week -5)

Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal

Timeframe: Baseline

Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test)

Timeframe: Baseline

Phase 2: Percent Weight Loss

Timeframe: Week 0 (randomization) to week 24

Trial details

NCT IDNCT03779048

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-25

Results submitted2023-05-09

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity)
. Age ≥ 21 years and ≤ 70 years
. Eligible female patients will be:
. Subjects must:

Exclusion criteria

. Pregnant or nursing, or plans to become pregnant in the next 9 months.
. Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg)
. Type 1 diabetes

What they're measuring

Phase 1: Percent Weight Loss

Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)

Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss

Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)

Timeframe: Baseline (week -5)

Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal

Timeframe: Baseline

Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test)

Timeframe: Baseline

Phase 2: Percent Weight Loss

Timeframe: Week 0 (randomization) to week 24